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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stopcock, i.v. set
510(k) Number K022895
Device Name ELCAM STOPCOCKS AND MANIFOLDS
Original Applicant
MEDICAL DEVICE CONSULTANTS, INC.
49 plain st.
north attleboro,  MA  02760 4153
Original Contact daniel j dillon
Regulation Number880.5440
Classification Product Code
FMG  
Date Received09/03/2002
Decision Date 10/18/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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